Ignite Creation Date:
2024-05-06 @ 12:14 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01529476
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2012-01-31
Brief Title:
Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
Sponsor:
TaiGen Biotechnology Co Ltd
Organization:
TaiGen Biotechnology Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Comparative Multi-Center Study of the Safety and Efficacy of TG-873870Nemonoxacin Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia CAP
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 This study will test the safety and efficacy of TG-873870 Nemonoxacin compared with Levofloxacin in adult patients with Community-Aquired Pneumonia CAP
2 To investigate the population pharmacokinetics PPK of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic PKpharmacodynamic PD
2 To investigate the population pharmacokinetics PPK of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic PKpharmacodynamic PD
Detailed Description:
Community-acquired Pneumonia CAP remains a leading cause of death in both developing and developed countries In the choice of antibacterial agents used to treat CAP fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity TG-873870 Nemonoxacin a non-fluorinated quinolone NFQ is a selective bacterial topoisomerase inhibitor This study will test the safety and efficacy of TG-873870 Nemonoxacin compared with Levofloxacin in adult patients with Community-Aquired Pneumonia CAP
Besidesthe population pharmacokinetics PPK of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic PKpharmacodynamic PD
Besidesthe population pharmacokinetics PPK of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic PKpharmacodynamic PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None